FDA 510(k) Application Details - K981645

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K981645
Device Name	Clip, Implantable
Applicant	VITALITEC INT'L., INC. 15 CASWELL LN. 3RD FLOOR PLYMOUTH, MA 02360 US Other 510(k) Applications for this Company
Contact	ELLEN HENKE-KNUPP Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/1998
Decision Date	10/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review